RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic
RESPOND
1 other identifier
interventional
212
1 country
1
Brief Summary
This randomized controlled trial will evaluate the implementation and (cost-)effectiveness of the culturally and contextually adapted Doing What Matters in times of stress (DWM) and Problem Management Plus (PM+) stepped-care programs amongst asylum seekers, refugees, and/or migrants living in Italy. Outcomes include mental health, resilience, wellbeing, health inequalities, and costs to health systems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedStudy Start
First participant enrolled
December 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedJanuary 5, 2022
December 1, 2021
1.4 years
August 5, 2021
December 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Health Questionnaire - Anxiety and Depression (PHQ-ADS)
Decrease in symptoms of depression and anxiety. The total score ranges from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.
Two-month follow-up after the PM+ intervention ended
Secondary Outcomes (6)
Patient Health Questionnaire (PHQ-9)
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)
Generalized Anxiety Disorder checklist (GAD-7)
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)
PTSD Checklist for DSM-5 (PCL-5)
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)
EuroQol five dimension five level checklist for quality of life EU European Union (EQ-5D-5L)
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)
Mainz Inventory of MIcrostressorS (MIMIS) and stressful events
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)
- +1 more secondary outcomes
Study Arms (2)
Psychological First Aid + Stepped-care intervention (DWM/PM+)
EXPERIMENTALAll participants will be offered individual Psychological First Aid (PFA), a WHO developed support strategy that involves humane, supportive and practical help for individuals suffering from serious humanitarian crises. The treatment group will receive the stepped-care program consisting of DWM (step 1) and Problem Management Plus (PM+). The DWM program has been developed by WHO and collaborators working in the humanitarian field. DWM was designed to be relevant for large segments of adversity-affected populations: it is intended to be transdiagnostic, and easily adaptable to different cultures and languages. PM+ is a new, brief, psychological intervention program based on cognitive-behavioral therapy (CBT) techniques that are empirically supported.
Psychological First Aid + usual care
OTHERAll participants will be offered individual Psychological First Aid (PFA), a WHO developed support strategy that involves humane, supportive and practical help for individuals suffering from serious humanitarian crises. In addition, both the groups will receive care-as-usual (CAU); they will be allowed to receive any usual care. CAU may include community care, social/legal support, and psychoeducation.
Interventions
The DWM program consists of a self-help guide that is complemented with pre-recorded audio exercises. The audio material imparts key information about stress management and guides participants through individual exercises. Additionally, participants are guided by a briefly trained helper. DWM includes five sections (or modules), each of which focuses on a specific skill. In this study, the DWM program will be delivered as an online intervention. The DWM intervention, i.e. both the audios and the self-help guide, have been adapted for use on a smartphone or other device with internet access. PM+ is a new, brief, psychological intervention program based on cognitive-behavioral therapy (CBT) techniques. The manual involves the following empirically supported elements: problem solving plus stress management, behavioral activation, facing fears, and accessing social support.
All participants, both in the treatment and the comparison group, will be offered individual Psychological First Aid (PFA) through a face-to-face or teleconferencing meeting. In addition to PFA, both the treatment and the comparison group will receive care-as-usual (CAU); they will be allowed to receive any usual care. CAU may include community care, social/legal support, and psychoeducation.
Eligibility Criteria
You may qualify if:
- years or older;
- Living in Italy as asylum seeker, refugee, or migrant
- Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) \>15.9).
- Sufficient mastery (written and spoken) of one of the languages the DWM/PM+ intervention is being delivered in (e.g. English, Italian).
- Oral and written informed consent before entering the study.
You may not qualify if:
- Planning to permanently move back to their home country before the last quantitative assessment at 2 months after PM+;
- Having acute medical conditions (requiring hospitalization);
- Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up;
- Having a severe mental disorder (e.g. psychotic disorders, substance-dependence);
- Having severe cognitive impairment (e.g. severe intellectual disability or dementia);
- Currently receiving specialized psychological treatment (e.g. Eye Movement Desensitization and Reprocessing - EMDR; Cognitive behavioural therapy - CBT);
- In case of current psychotropic medication use: being on an unstable dose for at least 2 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universita di Veronalead
- VU University of Amsterdamcollaborator
- Universidad Autonoma de Madridcollaborator
- London School of Economics and Political Sciencecollaborator
- Sorbonne Universitycollaborator
- Mainz Universitycollaborator
Study Sites (1)
Università di Verona
Verona, VR, 37134, Italy
Related Publications (1)
Purgato M, Turrini G, Tedeschi F, Serra R, Tarsitani L, Compri B, Muriago G, Cadorin C, Ostuzzi G, Nicaise P, Lorant V, Sijbrandij M, Witteveen AB, Ayuso-Mateos JL, Mediavilla R, Haro JM, Felez-Nobrega M, Figueiredo N, Pollice G, McDaid D, Park AL, Kalisch R, Petri-Romao P, Underhill J, Bryant RA, Nose M, Barbui C. Effectiveness of a stepped-care programme of WHO psychological interventions in migrant populations resettled in Italy: Study protocol for the RESPOND randomized controlled trial. Front Public Health. 2023 Jan 25;11:1100546. doi: 10.3389/fpubh.2023.1100546. eCollection 2023.
PMID: 36761135DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Assistant Professor, clinical psychologist
Study Record Dates
First Submitted
August 5, 2021
First Posted
August 6, 2021
Study Start
December 14, 2021
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
January 5, 2022
Record last verified: 2021-12